The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Dental Electrononic Anesthesia (dea0 System 8670 Additional Applications.
| Device ID | K935085 |
| 510k Number | K935085 |
| Device Name: | 3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS |
| Classification | Device, Electrical Dental Anesthesia |
| Applicant | 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Contact | Paul A Burgio |
| Correspondent | Paul A Burgio 3M COMPANY 3M CENTER BLDG. 275-3SE-08 St. Paul, MN 55144 -1000 |
| Product Code | LWM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-22 |
| Decision Date | 1994-01-26 |